Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012392312

FEI Number

3012392312

Entity Name

Joerns Healthcare

City/State/Country

Charlotte, NC, US

Establishment Address

2430 Whitehall Park Dr Ste 700, Charlotte, NC 28273, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

JOERNS HEALTHCARE LLC (Owner Number: 9105099)

Owner / Operator Contact Address

2100 Design Road, --, Arlington, TX 76014, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PrevaMatt Defend PrevaMatt Ultra ProCair V/VR Bodywrap P.R.O. MATT Mattress PrevaMatt Basic PrevaMatt Console PrevaMatt Alleviate DermaTech PrevaMatt Ease PrevaMatt Emmerse BariMatt 1000 Plus Imprint Foam Headcradles Foam Bolsters/Extenders, Siderails Foam Heel/Ankle/Foot protectors Foam Abduction Pillows Foam Arm/Elbow/Ulnar Protectors Foam Pillows Foam Wedges/Aligners Foam Donuts CareChair DermaFloat LAL Arise LAL Cair APM Arise 1000EX ProCair Plus Cair LAL Alternate Cair Plus TxCair Plus DermaFloat APL Dolphin Fluid Immersion System DermaFloat APM FlapCair CairTurn P.R.O. Matt Plus Cair 1000 LAL Care100 Bed UCXT Bed Panacea 2000 RC Ultra Hi-Lo Bed EasyCare Bed Panacea 1000 - FLEX Panacea 1750 WeCare Institutional WeCare Home Bed WeCare Institutinal Bolted Frame Foam Headcradles Foam Arm/Elbow/Ulnar Protectors HOYER JOURNEY HOYER STATURE HOYER ELARA4-625 Sling Easy-fit Hoyer Switch Sling Dress Toileting Sling Comfort HOYER ELARA2-625 HOYER CALIBRE Hoyer Sling HOYER ADVANCE-H Sling Transfer Sling Stand Assist HOYER ASCEND C-HLA-2T HML400 Hoyer Up 440 Sling Cradle HOYER PRESENCE HOYER ELARA4-500 HOYER ADVANCE-E Sling Universal HOYER ELARA2-500 HPL500 HOYER ELEVATE SS-HSP HPL700 HPL402 C-HLA HOYER VOYAGER C-CB-L2 HPL 450-EL Full Back Sling QuickFit Sling Access Sling HML450 Bariatric Full Back Sling Seat/Back Sling Longseat Sling Deluxe Transport Sling HPL 450-ML QuickFit Deluxe Sling One Piece Commode Sling Comfort Amputee Sling Deluxe Stand Aid Sling Sliding Sheet One Piece Sling RC 1000 Bed RC 750 Bed RCUltra Hi-Lo 850 Bed Bari10A Bed Mattress Cover Seating Cushion Cover Stretcher Pad Cover

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IKY	Mattress, Flotation Therapy, Non-Powered	General Hospital	Class 1	880.5150	1992-12-14
FMP	Protector, Skin Pressure	General Hospital	Class 1	880.6450	1992-12-14
BYN	Chair, Posture, For Cardiac And Pulmonary Treatment	Anesthesiology	Class 1	868.5365	2016-11-14
FNM	Mattress, Air Flotation, Alternating Pressure	General Hospital	Class 2	880.5550	1997-09-16
FNL	Bed, Ac-Powered Adjustable Hospital	General Hospital	Class 2	880.5100	1992-11-17
MRI	Orthosis, Truncal/Orthosis, Limb	Physical Medicine	Class 1	890.3490	2002-07-02
FSA	Lift, Patient, Non-Ac-Powered	General Hospital	Class 1	880.5510	1996-08-29
OSI	Bariatric Bed	General Hospital	Class 2	880.5100	2018-01-25
FMW	Cover, Mattress (Medical Purposes)	General Hospital	Class 1	880.6190	1992-12-14

Official Correspondent

Rick Willis

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

JOERNS HEALTHCARE LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3018084435	Joerns Healthcare Brownsville	Brownsville, TX, US
3009402404	Joerns Healthcare	Arlington, TX, US
3009525805	Joerns Healthcare Matamoros	H. Matamoros, Tamaulipas Mexico, MX

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K935837	Healthcare Designs	AIRHYTHM HEALTHCARE BED	1994-06-21

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0016-2007	Sunrise Medical CCG, Inc.	2	Joerns Ultra Care 770 Model AC Powered Beds with model numbers U770, U770 AL , U770 GNDAL. Sunrise Medical, Long Term Care Division, 5001 Joerns Drive, Stevens Point, WI 54481 USA.
Z-0017-2007	Hill-Rom, Inc.	2	Hill-Rom VersaCare Hospital Bed with optional patient pendant P3207A01 or P3207A02; model P3200.
Z-0019-2015	Arjo Hospital Equipment AB Verkstadsvagen	2	ArjoHuntleigh Contoura C1000 series beds are designed to accommodate patients weighing up to 990 lbs. (450 kg). Model C1000 is the basic bed. Model C1080 includes a weighing system and a power outlet for an ArjoHuntleigh approved mattress pump. Product Usage: The Contoura series bariatric beds are electrically operating medical beds with a maximum patient weight of 450 kg. This range is intended for use in hospitals to facilitate management of obese patients. An optional integrated weighing system helps with assessment and management of the patient if required.
Z-0026-2007	Extended Care Air Therapy Systems Inc	2	ECAT (Extended Care Air Therapy Systems) 2000 Safe Enclosure Bed
Z-0013-2018	Handicare Usa Inc	1	PRISM MEDICAL A-625, MAX. LOAD 625 lbs. 283 Kgs., Patient lift, non-A/C powered

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012392312. Last updated year: 2026. Please use registration number 3012392312 when referencing this establishment in official correspondence.